Today we’d like to introduce you to Ytziel Ordosgoite.
Hi Ytziel, so excited to have you with us today. What can you tell us about your story?
As an Engineer with over two decades of experience in Quality and Regulatory Affairs, I have worked with multinational companies in the consumer goods sector. Over eight years ago, I discovered a new professional path in the medical device industry, where I continued to grow and specialize, this time navigating the demanding and highly detailed world of FDA regulations.
During this chapter, I registered medical device establishments, supported companies in third-party audits, and led FDA inspections. Immersed in this landscape, I realized how many companies, especially small ones, struggled to bring safe and compliant devices to market. Simple regulatory oversights, such as missing or incorrect UDI (Unique Device Identifiers) on their medical device labels, often put their business potential at risk. With the experience I had gained over the years in the medical device field, I decided to help small businesses meet FDA regulatory requirements.
In March 2024, I founded AYM Consulting Services LLC, driven by the purpose of guiding small and emerging medical device manufacturers in their journey toward FDA compliance. Our mission is to simplify regulatory processes so manufacturers can focus on innovation and patient safety.
Behind this mission, however, there is also a personal story. As a businesswoman, mother, and wife, I have learned to balance responsibility, resilience, and vision. Building AYM has shown me that success is not only about expertise, it is also about determination, discipline, and the ability to make room for what truly matters. Each day, I dedicate myself to helping small businesses in the United States comply with the regulatory requirements established by the FDA, while still being fully present for my family. This journey has been both challenging and deeply rewarding, and it continues to inspire the purpose behind AYM: empowering others to grow, thrive, and reach new possibilities.
We all face challenges, but looking back would you describe it as a relatively smooth road?
Balancing family life with helping companies achieve their goals has not always been easy. Early mornings and late nights are often necessary, yet every sacrifice is rewarding, knowing that my work helps others succeed and make a real impact.
Appreciate you sharing that. What should we know about AYM Consulting Services LLC?
AYM Consulting Services LLC is a company dedicated to supporting small and emerging medical device manufacturers in navigating the complex regulatory landscape of the United States. We specialize in FDA compliance, helping companies ensure their devices meet all required standards, from registration of establishments to labeling compliance, including UDI (Unique Device Identifiers), audits, and inspections.
What sets us apart is our hands-on, personalized approach. We understand the challenges small businesses face, and we focus on making regulatory processes simpler so manufacturers can concentrate on what truly matters: innovation and patient safety. Our experience across multiple industries, combined with years of direct work in medical device compliance, allows us to anticipate challenges, prevent common regulatory pitfalls, and guide our clients efficiently and effectively.
What we are most proud of is the impact we have on our clients’ success. Helping small companies bring safe, compliant products to the U.S. market and, seeing their growth and achievements, is incredibly rewarding.
We want your readers to know that AYM is more than a consulting service; we are a trusted partner in growth and compliance. Our mission is to empower small businesses to confidently navigate the FDA regulatory environment while maintaining focus on their innovation, their patients, and their goals.
What would you say have been one of the most important lessons you’ve learned?
This journey has taught me that unexpected paths often lead to our greatest growth. Following those new directions helped me discover my purpose: helping others reach their goals. Sometimes, the road you never planned to take becomes the one that transforms you the most.
Contact Info:
- Website: https://aymconsultingllc.com/
- Instagram: https://www.instagram.com/aymconsultingllc/
- Facebook: https://www.facebook.com/aymconsultingllc
- LinkedIn: https://linkedin.com/in/ytziel-ordosgoite-1719035a
